A Post-Market Prospective Evaluation of the Performance and Safety of the Ellipse PRECICE Intramedullary Limb Lengthening System

Further study details as provided by Ellipse Technologies, Inc.:

Primary Outcome Measures:

Distraction Control: actual distraction rate vs. target distraction rate [ Time Frame: Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bone Union [ Time Frame: Following completion of the subject's distraction regimen, every 4-6 weeks until the subject's treated limb is evaluated as consolidated, an expected average of 66 days ] [ Designated as safety issue: No ]

Pain [ Time Frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months ] [ Designated as safety issue: No ]

Healing Index [ Time Frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months ] [ Designated as safety issue: No ]

The total treatment period with the PRECICE System in situ, divided by the length of bone growth in centimeters.

Number of days to complete lengthening [ Time Frame: Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days ] [ Designated as safety issue: No ]

Number of days to complete full weight bearing [ Time Frame: Up to an expected average of 99 days. ] [ Designated as safety issue: No ]

Number of days to full consolidation [ Time Frame: Following completion of the subject's distraction regimen, every 4-6 weeks until the subject's treated limb is evaluated as consolidated, an expected average of 66 days ] [ Designated as safety issue: No ]

Adverse Events [ Time Frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months ] [ Designated as safety issue: Yes ]

Device-related complications [ Time Frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months ] [ Designated as safety issue: Yes ]

Procedure-related complications [ Time Frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months ] [ Designated as safety issue: Yes ]

All qualifying subjects enrolled are to be treated with the PRECICE Intramedullary Limb Lengthening System

Device: PRECICE System

PRECICE System implantation into the subject's femur or tibia

Eligibility

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Leg length discrepancy ≥ 1.5 cm and ≤ 6.5 cm due to short femur or tibia

Weight ≤ 114 kg

Skeletally mature

Intramedullary canal without offset

Tibia or femur sufficient to contain the implant

Availability, willingness, and sufficient cognitive awareness to comply with protocol procedures and schedule

Must sign informed consent to permit the use of personal health data

Exclusion Criteria:

Active infection or previous history of deep infection in the involved bone

Metal allergies or sensitivities to the components of the device

Distance from the nearest convenient external surface of the treated limb to the intramedullary canal > 51 mm for the 10.7 mm PRECICE System or > 76 mm for the 12.5 mm PRECICE System

Significant range of motion deficit of the adjacent joints

Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic or magnetic implant

Patients who require an MRI during implantation

Non-union

Impassable or obstructed intramedullary canal

Significant angular deformity that prevents device placement

Cannot bear weight on the contralateral limb

Procedural osteotomy cannot be made in an appropriate location

Deformities that require multilevel osteotomies or bi-lateral implantation at the time of study index surgery

Systemic bone disease

Pregnant or nursing women

Inadequate vascularity or evidence of vascular disease or peripheral neuropathy

Malignancies or tumors in the involved bone

Patient is a drug abuser

Open wounds or ulcers that could compromise treatment

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601301